Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070311
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DIAZEPAM | DIAZEPAM | 5MG/ML (5MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/16/1985 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/01/2026 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2024 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2023 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2021 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/070311s022lbl.pdf | |
| 05/17/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/08/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/01/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/07/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/26/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/12/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/070311s022lbl.pdf |
DIAZEPAM
INJECTABLE;INJECTION; 50MG/10ML (5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216422 | GALENICUM HLTH |
| DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 070311 | HIKMA |
| DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 071583 | HOSPIRA |
| DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 211998 | REGCON HOLDINGS |